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Questions and Answers: EPA Policy for Managing Risk to Workers from Organophosphate Pesticides (OPs)

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Current as of: December 2000
EPA 735-F-00-008

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What action has EPA taken?

On September 29, 2000, EPA issued a policy statement known as a Pesticide Registration (PR) Notice (2000-9) (PDF) (2 pp, 20K, About PDF)that announces EPA's approach for managing risks to workers who may be exposed to organophosphate (OP) pesticides.

Why did EPA issue this PR Notice?

OP pesticides can pose significant health risks to people who are exposed to them through their work. Effective and manageable safety precautions are essential for ensuring that these pesticides can be used without posing unreasonable risks to workers. Generally, the Agency develops risk mitigation measures for pesticides as part of its decisions for new registrations, or for reregistration of older pesticides. EPA is currently developing and implementing chemical specific risk mitigation strategies for the OPs. We are providing this document to give stakeholders notice about the types of risk mitigation actions the Agency may include when completing a Reregistration Eligibility Decision (RED), an Interim RED (IRED), or a Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision, known as a TRED for an OP pesticide. The notice should thereby help ensure that decisions to reduce worker risks will be implemented quickly and equitably. The notice, however, does not impose binding obligations on the registrants or on EPA.

In a number of cases the OP risk assessments show that risks to workers still exceed the Agency's levels of concern, even when maximum feasible personal protective equipment (PPE) and engineering controls, including all provisions currently required by the Worker Protection Standard, are employed. Thus, EPA encourages registrants to demonstrate stewardship of their chemicals by adopting the protective measures described in the PR notice before the Agency issues the mitigation decisions for their OP pesticides. We also encourage registrants to develop new packaging and application technologies that reduce worker exposures to pesticides.

Whom does the notice affect?

The approach described in the notice applies to both workers and handlers as defined by the Worker Protection Standard (WPS), and other persons not specifically covered by WPS (such as people who handle pesticides or are exposed following applications to rangeland, rights-of-way, structures, livestock, golf courses, parks, public spaces, etc.), who nonetheless perform similar activities and are exposed to pesticides in a similar manner to agricultural workers.

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What types of risk mitigation will EPA consider?

The notice describes a range of risk mitigation measures that EPA will consider when assessing OP pesticides to reduce risks to workers, which may include the following: use of additional Personal Protective Equipment (PPE), closed mixing and loading systems, enclosed cabs, enclosed cockpits, reduced application rates, reduced frequency of applications, mechanical harvesting, and longer restricted entry intervals (REIs).

What approaches will EPA take to manage worker risk?

In completing an OP risk management decision for workers, the Agency will generally follow a six step approach:

Estimating Worker Risk

EPA estimates worker risk by comparing estimates of occupational exposure levels, including both dermal and inhalation exposures, against the No Observed Adverse Effect Level (NOAEL) demonstrated in toxicity studies. The ratio of the estimated exposure to the NOAEL is referred to as the Margin of Exposure (MOE). Generally, MOEs that are less than 100 exceed the Agency's level of concern for worker risk.

  1. Evaluate Current Uses: EPA will first determine whether or not existing uses have adequate margins of exposure (MOE) based on available data (see side box) and information about product uses and restrictions from current labeling. Worker risks for which the MOE is at or above the target MOE (typically 100) are not considered to be of concern. In such cases, the Agency generally will not pursue additional risk reduction measures.


  2. Mitigate Risks of Concern: For uses with MOEs of concern (generally < 100) based on current labeling, EPA will seek to reduce risks to workers to the greatest extent feasible with PPE and engineering controls, as well as application modifications such as decreased application rates. Based on the Agency's experience with the OP occupational risk assessments completed thus far, this approach will include the use of closed mixing and loading systems and enclosed cab/cockpit equipment for pesticide applications for many outdoor agricultural uses.


  3. Use Maximum Feasible PPE: Where engineering controls are not feasible due to logistical constraints, for example, greenhouse applications, EPA intends to seek maximum feasible personal protective equipment (PPE), which may include 2 layers of clothing, chemical resistant gloves, footwear, headgear, apron, and respirators where appropriate. EPA may also seek modifications in use patterns, application equipment or formulation systems.


  4. Restrict or Prohibit Human Flaggers: Due to the availability of mechanical flaggers and global positioning systems, the application industry is moving away from the use of human flaggers, which operate by standing in the field to help direct pilots or ariel applicators. The Agency may seek to prohibit the use of human flaggers or restrict the use of human flaggers to enclosed cabs where the risk assessment warrants mitigation for these workers.


  5. Extend REIs: For harvesters and other workers who need to reenter treated fields, if MOEs based on existing REIs (restricted entry intervals) are inadequate, EPA will likely seek to increase the REIs in order to provide greater protection to these reentry personnel, or require changes in use patterns to reduce residues following applications.


  6. Cancel Use If Necessary: In situations where the MOEs are inadequate and risks continue to exceed benefits even after consideration of maximum PPE, engineering controls and modifications to the use pattern, the Agency will consider canceling the use. For example, certain application methods, such as hand-held equipment (backpack sprayers, handwands and knapsacks), may have risks that exceed benefits even after consideration of PPE, engineering controls or modified use patterns.

When will the Agency formally implement risk mitigation plans?

The risk mitigation plan, which is developed in the concluding phases of the OP pilot public participation process, will be outlined in one of three documents: an IRED, a TRED, or a RED. Generally these risk management decisions should be implemented for the growing season following the publication of the interim decision document

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Does the PR Notice cover non-OP pesticides?

Risks to workers exposed to classes of pesticides other than OPs, but which pose similar risks, e.g. carbamate pesticides, will be managed in a similar manner.

Was the PR Notice issued as a draft?

List of Acronyms and Terms

EPA: U.S. Environmental Protection Agency
FQPA: Food Quality Protection Act
MOE: Margin of Exposure
NOAEL: No Observable Adverse Effects Level
OP: Organophosphate
OPP: Office of Pesticide Programs
PPE: Personal Protective Equipment
PR Notice: Pesticide Registration Notice
REI: Restricted Entry Interval
Registrant: One who holds the registration or license for a pesticide product.

On August 6, 1999, EPA issued a Federal Register notice to elicit comments on the draft PR notice. The Agency received comments from government agencies (California and Canada), public interest groups, worker protection organizations, industry, and the National Agricultural Aviation Association. EPA took these comments into consideration when preparing the final notice. A Response to Comments document is available on-line at www.epa.gov/PR_Notices/draftprworker-response.htm.

How do I obtain more information?

For a copy of the OP Worker Risk Mitigation PR Notice (#2000-9), please visit OPP's web site at www.epa.gov/PR_Notices/.

For specific questions about this PR Notice, or if you would like a paper version of this document, please contact Kathleen Meier (meier.kathleen@epa.gov) by telephone at (703) 308-8017; by fax at (703) 308-8041

For general information about pesticides, please contact (703) 305-5017, or visit the Office of Pesticide Programs' Internet site

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